FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
H-H ALIMENTATION CATHETERS
K Number: K821012
·
Decision May 28, 1982
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
64
Applicant Total
42
Review Days
46
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Basic Information
- Device Name
- H-H ALIMENTATION CATHETERS
- K Number
- K821012
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Holter-Hausner Intl.
- Date Received
- April 12, 1982
- Decision Date
- May 28, 1982
- Product Code
- LFJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LFJ | Catheter, Subclavian | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Holter-Hausner Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K875287 | H-H FLUSHING RESERVOIR | Jul 14, 1988 | Substantially Equivalent |
| K874508 | H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG | Jan 19, 1988 | Substantially Equivalent |
| K872285 | H-H HUNTER ACTIVE TENDON IMPLANT DC | Sep 28, 1987 | Substantially Equivalent for Some Indications |
| K872284 | H-H HUNTER ACTIVE TENDON IMPLANT PC | Sep 28, 1987 | Substantially Equivalent for Some Indications |
| K872293 | H-H HUNTER ACTIVE TENDON IMPLANT BC | Sep 28, 1987 | Substantially Equivalent for Some Indications |
| K871351 | H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP | May 14, 1987 | Substantially Equivalent |
| K870660 | H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS | May 1, 1987 | Substantially Equivalent |
| K865075 | H-H SUBGALEAL TROCAR | Jan 13, 1987 | Substantially Equivalent |
| K853436 | H-H HUNTER PASSIVE TENDON IMPLANT | Oct 16, 1985 | Substantially Equivalent |
| K853437 | H-H HUNTER TENDON ROD | Oct 16, 1985 | Substantially Equivalent |